agonists.
Sodium content
Aggrastat Solution
Aggrastat solution for infusion contains approximately 917 mg of sodium per 250 ml bag which should be taken into consideration by patients on a controlled sodium diet.
Aggrastat Concentrate
Aggrastat concentrate for solution for infusion contains approximately 189 mg of sodium per 50 ml vial which should be taken into consideration by patients on a controlled sodium diet.
**TIMI major bleeds are defined as a haemoglobin drop of > 50 g/l with or without an identified site, intracranial haemorrhage, or cardiac tamponade. TIMI minor bleeds are defined as a haemoglobin drop of > 30 g/l but ≤ 50 g/l with bleeding from a known site or spontaneous gross haematuria, haematemesis, or haemoptysis. TIMI “loss no site” is defined as a haemoglobin drop > 40 g/l but < 50 g/l without an identified bleeding site.
The use of several platelet aggregation inhibitors increases the risk of bleeding, likewise their combination with heparin, warfarin and thrombolytics. Clinical and biological parameters of haemostasis should be regularly monitored.
The concomitant administration of Aggrastat and ASA increases the inhibition of platelet aggregation to a greater extent than ASA alone, as measured by ex vivo APD-induced platelet aggregation test. The concomitant administration of Aggrastat and unfractionated heparin increases the prolongation of the bleeding time to a greater extent as compared to unfractionated heparin alone.
With the concurrent use of Aggrastat, unfractionated heparin, ASA, and clopidogrel there was a comparable incidence of bleeding than when only unfractionated heparin, ASA, and clopidogrel were used together (see sections 4.4 and 4.8).
Aggrastat prolonged bleeding time; however, the combined administration of Aggrastat and ticlopidine did not additionally affect bleeding time.
Concomitant use of warfarin with Aggrastat plus heparin was associated with an increased risk of bleeding.
Aggrastat is not recommended in thrombolytic therapy - concurrent or less than 48 hours before administration of tirofiban hydrochloride or concurrent use of drugs that increase the risk of bleeding to a relevant degree (e.g. oral anticoagulants, other parenteral GP IIb/IIIa inhibitors, dextran solutions). There is insufficient experience with the use of tirofiban hydrochloride in these conditions; however, an increased risk of bleeding is suspected.
Pregnancy
There are no or limited amount of data from the use of tirofiban hydrochloride in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Aggrastat is not recommended during pregnancy unless clearly necessary.
Breastfeeding
It is unknown whether tirofiban hydrochloride is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of tirofiban hydrochloride in milk (for details see section 5.3). A risk to the newborn cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Aggrastat therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
Fertility and reproductive perfor
